"Nov. 20, 2012 -- Oral contraceptives should be made available without a prescription to reduce unintended pregnancies, according to a newly published opinion by the American College of Obstetricians and Gynecologists (ACOG).
Endometrin Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Endometrin (progesterone) Vaginal Insert is a progestin used to help support pregnancy in women who have fertility problems. Common side effects of Endometrin include bloating, stomach pain, nausea, breast tenderness, headache, drowsiness, mood swings, irritability, and vaginal discomfort.
The recommended dosage of Endometrin is one 100 mg application 2 to 3 times per day. If you become pregnant continue using Endometrin for 10 weeks. Rifampin, St. John's wort, azoles, itraconazole, carbamazepine, phenobarbital, and phenytoin may interact with Endometrin. Tell your doctor all medications you take. Do not drive, use machinery, or do any activity that requires alertness after taking Endometrin. Avoid alcohol while taking Endometrin. Talk to your doctor if you are breastfeeding while taking Endometrin.
Our Endometrin (progesterone) Vaginal Insert Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Endometrin in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:
- sudden headache, numbness or weakness (especially on one side of the body), shortness of breath, or problems with vision, speech, or balance;
- chest pain or heavy feeling, pain spreading to the arm or shoulder;
- pain or swelling in one or both legs;
- nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
- swelling in your hands, ankles, or feet;
- fever, chills, body aches, flu symptoms;
- a breast lump; or
- symptoms of depression (sleep problems, weakness, mood changes).
Less serious side effects may include:
- mild nausea, vomiting, bloating, stomach cramps;
- diarrhea, constipation, bloating;
- dizziness, drowsiness, tired feeling;
- pain in your vaginal or rectal area;
- pain during intercourse;
- loss of interest in sex;
- breast pain, swelling, or tenderness;
- joint or muscle pain;
- increased night-time urination; or
- vaginal itching, burning, or discharge.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Endometrin (Progesterone) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Endometrin Overview - Patient Information: Side Effects
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor immediately if any of these unlikely but serious side effects occur: unusual vaginal bleeding, severe mental/mood changes (e.g., depression), swelling ankles/feet, yellowing eyes/skin, breast lumps.
This medication may rarely cause very serious problems from blood clots (e.g., heart attack, stroke, blood clots in the lungs/legs, blindness). Seek immediate medical attention if you have any of the following symptoms: chest/jaw/left arm pain, weakness on one side of the body, slurred speech, difficulty walking, sudden vision/eye changes (e.g., blurred/double vision, loss of vision, bulging eyes), confusion, sudden severe headache, severe dizziness, fainting, trouble breathing, coughing up blood, pain/redness/swelling/weakness of the arms/legs, calf pain/swelling that is warm to the touch.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Endometrin (Progesterone)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Endometrin FDA Prescribing Information: Side Effects
Clinical Studies Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety data reflect exposure to Endometrin in 808 infertile women (74.9% White, 10.3% Hispanic, 5.4% Black, 5% Asian, and 4.6% Other) in a single Assisted Reproductive Technology 10 week clinical study conducted in the U.S. Endometrin was studied at doses of 100 mg twice daily and 100 mg three times daily. The adverse reactions that occurred at a rate greater than or equal to 2% in either Endometrin group are summarized in Table 1.
Table 1: Number and Frequency of Reported
Adverse Reactions in Women Treated with Endometrin in an Assisted Reproductive
|Body System Preferred Term||Endometrin 100 mg twice daily (N=404)||Endometrin 100 mg three times daily (N=404)|
|Abdominal pain||50 (12%)||50 (12%)|
|Nausea||32 (8%)||29 (7%)|
|General Disorders and Administration Site Conditions|
|Infections and Infestations|
|Urinary tract infection||9(2%)||4 (1%)|
|Injury, Poisoning and Procedural Complications|
|Post-ooctye retrieval pain||115(28%)||102 (25%)|
|Nervous System Disorders|
|Reproductive System and Breast Disorders|
|Ovarian hyperstimulation syndrome||30 (7%)||27 (7%)|
|Uterine spasm||15(4%)||11 (3%)|
|Vaginal bleeding||13(3%)||14 (3%)|
Expected Adverse Reaction Profile Seen with Progesterone
Endometrin is also expected to have adverse reactions similar to other drugs containing progesterone that may include breast tenderness, bloating, mood swings, irritability, and drowsiness.
Read the entire FDA prescribing information for Endometrin (Progesterone) »
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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